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Effect of Statins on the Radial Intima-media Thickness After Transradial Angioplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Chungnam National University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chungnam National University
ClinicalTrials.gov Identifier:
NCT00952770
First received: August 4, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

The first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall. After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and recruitment of monocytes to the intima and media are the next steps. The thickening of intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily measured by high-resolution ultrasonography in various arteries including carotid, brachial and radial arteries. The increased carotid IMT can be used as a non-invasive independent parameter indicating increased cardiovascular mortality. Some investigators reported increased radial IMT is associated with increased early failure of the radiocephalic arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in patients underwent radial artery intervention because of denudation injury of the radial artery. Recently, the use of statin can halt the progression of the carotid IMT progression. However, it is unknown that the use of statin can prevent the progression of radial IMT after the transradial coronary intervention. The investigators want to evaluate the effect of statins on the progression of the radial IMT after the transradial intervention.


Condition Intervention Phase
Coronary Artery Disease
Procedure: transradial coronary intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Statins on the Progression of the Intima-media Thickness of the Radial Artery After Radial Angioplasty

Resource links provided by NLM:


Further study details as provided by Chungnam National University:

Primary Outcome Measures:
  • Difference of IMT between two groups [ Time Frame: 1 month, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference of epicardial fat thickness Difference of cholesterol level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: July 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
Group receiving atorvastatin 20mg/day
Procedure: transradial coronary intervention
percutaneous coronary intervention with transradial approach
Active Comparator: Simvastatin/Ezetimibe
Group receiving simvastatin/ezetimibe 10/10mg
Procedure: transradial coronary intervention
percutaneous coronary intervention with transradial approach

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing coronary intervention via the radial artery

Exclusion Criteria:

  • Contraindication to statins
  • Left ventricular ejection fraction less than 30%
  • Recent history of hematologic disease or leukocyte count <3000/mm3 and/or platelet <100 000/mm3
  • Hepatic dysfunction with AST or ALT >3 times the upper normal reference limit
  • History of renal dysfunction or a serum creatinine level >2.0 mg/dL
  • Serious noncardiac comorbid disease with a life expectancy <1 year
  • Inability to follow the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952770

Contacts
Contact: Jae-Hyeong Park, MD, PhD 82-42-280-7167 jaehpark@cnuh.co.kr
Contact: Si Wan Choi, MD, PhD 82-42-280-8237 csw1967@cnuh.co.kr

Locations
Korea, Republic of
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jae-Hyeong Park, MD, PhD    82-42-280-7167    jaehpark@cnuh.co.kr   
Sponsors and Collaborators
Chungnam National University
Investigators
Principal Investigator: Jae-Hyeong Park, MD, PhD Chungnam National University, Chungnam National University Hospital
  More Information

No publications provided

Responsible Party: Jae-Hyeong Park, MD, PhD, Chungnam National University, Chungnam National University Hospital
ClinicalTrials.gov Identifier: NCT00952770     History of Changes
Other Study ID Numbers: CNUH-09-07-60
Study First Received: August 4, 2009
Last Updated: August 4, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chungnam National University:
Coronary artery disease
Coronary intervention
intima-media thickness

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014